Phase 3
Completed N=210
Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (H1N1) (GSK2340272A)
Source: ClinicalTrials.gov NCT00964158 ↗Enrolled (actual)
210
Serious AEs
0.5%
Results posted
Feb 2018
Primary outcomePrimary: Number of Subjects With Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value — 40 Participants
◆ Published Evidence
Established
34citations · ~2 / year
Immunogenicity and safety of AS03-adjuvanted H1N1 pandemic vaccines in children and adolescents.
Summary
This trial is designed to assess the safety and immunogenicity of a prime-boost schedule of GSK Biologicals' investigational vaccine GSK2340272A in children aged between 3 and 17 years.
Linked Publications (2)
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Immunogenicity and safety of AS03-adjuvanted H1N1 pandemic vaccines in children and adolescents.
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Safety and persistence of the humoral and cellular immune responses induced by 2 doses of an AS03-adjuvanted A(H1N1)pdm09 pandemic influenza vaccine administered to infants, children and adolescents: Two open, uncontrolled studies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value |
40 | — |
| PRIMARY Number of Subjects With HI Antibody Concentrations Above the Cut-off Value |
0; 6; 22; 41; 50; 87 | — |
| PRIMARY Titers for Serum HI Antibodies |
5.0; 6.3; 8.9; 168.3; 284.4; 547.9 | — |
| PRIMARY Titers for Serum HI Antibodies |
5.0; 6.3; 8.9; 168.3; 284.4; 547.9 | — |
| PRIMARY Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies |
41; 50; 85; 41; 49; 80 | — |
| PRIMARY Number of Seroprotected (SPR) Subjects in Terms of HI Antibodies |
194 | — |
| PRIMARY Seroconversion Factor (SCF) for HI Antibody Titers |
33.7; 44.9; 61.8; 316.2; 151.7; 119.8 | — |
| SECONDARY Number of Subjects With HI Antibody Concentrations Above the Cut-off Value |
0; 6; 22; 41; 50; 87 | — |
| SECONDARY Titers for Serum HI Antibodies |
5.0; 6.3; 8.9; 168.3; 284.4; 547.9 | — |
| SECONDARY Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies |
41; 50; 85; 41; 49; 80 | — |
| SECONDARY Number of Seroprotected Subjects in Terms of HI Antibodies |
0; 3; 12; 41; 50; 87 | — |
| SECONDARY Seroconversion Factor (SCF) for HI Antibody Titers |
33.7; 44.9; 61.8; 316.2; 151.7; 119.8 | — |
| SECONDARY Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value |
25; 32; 28 | — |
| SECONDARY Titers for Serum Neutralizing Antibodies |
269.1; 168.4; 118.1 | — |
| SECONDARY Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value |
25; 32; 28 | — |
| SECONDARY Titers for Serum Neutralizing Antibodies |
269.1; 168.4; 118.1 | — |
| SECONDARY Number of Seroconverted (SCR) Subjects in Terms of H1N1 Neutralizing Antibodies |
24; 30; 25 | — |
| SECONDARY Number of Seroconverted (SCR) Subjects in Terms of H1N1 Neutralizing Antibodies |
24; 30; 25 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms |
40; 54; 91; 2; 3; 8 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms |
9; 26; 0; 1; 8; 26 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms |
9; 26; 0; 1; 8; 26 | — |
| SECONDARY Number of Subjects With Any Medically-attended Events (MAEs) |
36; 21; 33 | — |
| SECONDARY Number of Subjects With Any Adverse Events of Specific Interest (AESIs), Including Potential Immune-mediated Disease (pIMDs) |
0; 0; 0 | — |
| SECONDARY Number of Subjects With Normal or Abnormal Biochemical Levels |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) |
37; 26; 41; 8; 4; 7 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) |
37; 26; 41; 8; 4; 7 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
0; 0; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
- Children, male or female, aged between 3 and 17 years at the time of the first study vaccination.
- Written informed consent obtained from the subject parent(s) or LAR(s) of the subject. Assent obtained from the subject when applicable.
- Healthy children as established by medical history and clinical examination when entering into the study.
- Parent/LAR with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user.
Exclusion Criteria
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
- Clinically or virologically confirmed influenza infection within six months preceding the study start.
- Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
- Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period.
- Acute disease and/or fever at the time of enrolment
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
- Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
- Previous administration of any H1N1 A/California-like vaccine.
- Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
- If the subject is female and if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series.
- Any known or suspected allergy to any constituent of influenza vaccines;a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
- Known use of an analgesic or antipyretic medication within 12 hours prior to first vaccination.
- Child in Care.
Data sourced from ClinicalTrials.gov (NCT00964158) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.